Open Label Study Telmisartan and Amlodipine in Hypertension

• Sponsor: Boehringer Ingelheim (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00614380
• Collaborator: (none)
• Enrollment: 976
• Locations: 122
• Patients Per Site: 8

Study Details

Study Description

Brief Summary

The primary objective of this trial is to assess the efficacy and safety of the fixed dose combinations telmisartan 40 mg / amlodipine 5 mg (T40/A5) or telmisartan 80 mg / amlodipine 5 mg (T80/A5) during long-term open-label treatment.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: telmisartan/amlodipine 40/5 mg fixed combination; Drug: telmisartan/amlodipine 80/5 mg fixed combination	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 976 participants
• Primary Purpose: Treatment
• Official Title: An Open Label Follow-up Trial of the Efficacy and Safety of Chronic Administration of the Combination of Telmisartan 40mg + Amlodipine 5mg or the Combination of Telmisartan 80mg + Amlodipine 5mg Tablets Alone or in Combination With Other Antihypertensive Medications in Patients With Hypertension.
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Mar 1, 2009

Outcome Measures

Primary Outcome Measures

1. Trough Seated Diastolic Blood Pressure (DBP) Control [End of study (34 weeks or last value on treatment)]

   The number of patients who reach the target DBP of <90mmHg

Secondary Outcome Measures

1. Trough Seated Systolic Blood Pressure (SBP) Control [End of study (34 weeks or last value on treatment)]

   The number of patients who reach the target SBP of <140mmHg

2. Change From Baseline in Trough Seated Diastolic Blood Pressure [End of study (34 weeks or last value on treatment)]

   Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.

3. Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [End of study (34 weeks or last value on treatment)]

   The difference between the last available troughs represents the additional reduction in DBP in this study

4. Change From Baseline in Trough Seated Systolic Blood Pressure [End of study (34 weeks or last value on treatment)]

   Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.

5. Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7 [End of study (34 weeks or last value on treatment)]

   The difference between the last available troughs represents the additional reduction in SBP in this study

6. Trough Seated DBP Response [End of study (34 weeks or last value on treatment)]

   The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg

7. Trough Seated SBP Response [End of study (34 weeks or last value on treatment)]

   The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg

8. Trough Blood Pressure (BP) Normality Classes [End of study (34 weeks or last value on treatment)]

   The number of patients who reach predefined BP categories

9. Time to First Additional Antihypertensive [At any point during open-label treatment]

   Time from first intake of medication to first intake of an antihypertensive other than the study drug

10. Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control [At any point during open-label treatment]

    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment

11. Additional Reduction in DBP by Use of Additional Antihypertensive Therapy [At any point during open-label treatment]

    Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7

12. Additional Reduction in SBP by Use of Additional Antihypertensive Therapy [At any point during open-label treatment]

    Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7

13. Trough DBP Control Pre- and Post- Uptitration [At any point during open-label treatment]

    The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. patients aged at least 18 years

2. diagnosis of essential hypertension and blood pressure not adequately controlled before enrolment in the preceding trial.

3. failure to respond to six weeks treatment with Amlodipine 5 mg in the run-in period of the preceding trial.

Exclusion Criteria:

1. pre-menopausal women who are not surgically sterile; or are nursing or pregnant; or are not practising acceptable means of birth control or do not plan to continue using acceptable means of birth control throughout the study

2. development of any medical condition in the preceding trial that in the investigator's opinion could be worsened by treatment with either Telmisartan 40 mg/Amlodipine 5 mg or Telmisartan 80 mg/Amlodipine 5 mg

3. discontinuation from the preceding trial because of any adverse event or any other reason

4. known or suspected secondary hypertension

5. mean seated Systolic Blood Pressure => 180 mmHg and/or mean seated Diastolic Blood Pressure => 120 mmHg at any visit

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	1235.7.32004 Boehringer Ingelheim Investigational Site	Aywaille		Belgium
2	1235.7.32010 Boehringer Ingelheim Investigational Site	Gozée		Belgium
3	1235.7.32008 Boehringer Ingelheim Investigational Site	Linkebeek		Belgium
4	1235.7.32003 Boehringer Ingelheim Investigational Site	Mol		Belgium
5	1235.7.32007 Boehringer Ingelheim Investigational Site	Natoye		Belgium
6	1235.7.32002 Boehringer Ingelheim Investigational Site	Tienen		Belgium
7	1235.7.32005 Boehringer Ingelheim Investigational Site	Turnhout		Belgium
8	1235.7.20001 Boehringer Ingelheim Investigational Site	Coquitlam	British Columbia	Canada
9	1235.7.20011 Boehringer Ingelheim Investigational Site	Vancouver	British Columbia	Canada
10	1235.7.20007 Boehringer Ingelheim Investigational Site	Bay Roberts	Newfoundland and Labrador	Canada
11	1235.7.20005 Boehringer Ingelheim Investigational Site	Mount Pearl	Newfoundland and Labrador	Canada
12	1235.7.20008 Boehringer Ingelheim Investigational Site	St. John's	Newfoundland and Labrador	Canada
13	1235.7.20013 Boehringer Ingelheim Investigational Site	Corunna	Ontario	Canada
14	1235.7.20014 Boehringer Ingelheim Investigational Site	Etobicoke	Ontario	Canada
15	1235.7.20010 Boehringer Ingelheim Investigational Site	Hamilton	Ontario	Canada
16	1235.7.20012 Boehringer Ingelheim Investigational Site	London	Ontario	Canada
17	1235.7.20009 Boehringer Ingelheim Investigational Site	Ottawa	Ontario	Canada
18	1235.7.20006 Boehringer Ingelheim Investigational Site	Sarnia	Ontario	Canada
19	1235.7.20003 Boehringer Ingelheim Investigational Site	Sainte-Foy	Quebec	Canada
20	1235.7.45002 Boehringer Ingelheim Investigational Site	Birkerød		Denmark
21	1235.7.45005 Boehringer Ingelheim Investigational Site	Haderslev		Denmark
22	1235.7.45008 Boehringer Ingelheim Investigational Site	Herning		Denmark
23	1235.7.45009 Boehringer Ingelheim Investigational Site	Hinnerup		Denmark
24	1235.7.45001 Boehringer Ingelheim Investigational Site	Rødovre		Denmark
25	1235.7.45006 Boehringer Ingelheim Investigational Site	Rødovre		Denmark
26	1235.7.45003 Boehringer Ingelheim Investigational Site	Vaerløse		Denmark
27	1235.7.45007 Boehringer Ingelheim Investigational Site	Vildbjerg		Denmark
28	1235.7.35003 Boehringer Ingelheim Investigational Site	Joensuu		Finland
29	1235.7.35004 Boehringer Ingelheim Investigational Site	Joensuu		Finland
30	1235.7.35001 Boehringer Ingelheim Investigational Site	Turku		Finland
31	1235.7.35002 Boehringer Ingelheim Investigational Site	Turku		Finland
32	1235.7.3301H Boehringer Ingelheim Investigational Site	Aigrefeuille S/Maine		France
33	1235.7.3306C Boehringer Ingelheim Investigational Site	Angers		France
34	1235.7.3309B Boehringer Ingelheim Investigational Site	Angers		France
35	1235.7.3309C Boehringer Ingelheim Investigational Site	Angers		France
36	1235.7.3309E Boehringer Ingelheim Investigational Site	Angers		France
37	1235.7.3309D Boehringer Ingelheim Investigational Site	Avrille		France
38	1235.7.3309A Boehringer Ingelheim Investigational Site	Beaucouze		France
39	1235.7.3305A Boehringer Ingelheim Investigational Site	Bourg des cptes		France
40	1235.7.3306D Boehringer Ingelheim Investigational Site	Briollay		France
41	1235.7.3308B Boehringer Ingelheim Investigational Site	Cholet		France
42	1235.7.3308F Boehringer Ingelheim Investigational Site	Cholet		France
43	1235.7.3302C Boehringer Ingelheim Investigational Site	Garchizy		France
44	1235.7.3303C Boehringer Ingelheim Investigational Site	Grandchamps		France
45	1235.7.3302D Boehringer Ingelheim Investigational Site	Guerigny		France
46	1235.7.3310A Boehringer Ingelheim Investigational Site	Jarny		France
47	1235.7.3301L Boehringer Ingelheim Investigational Site	La Chapelle /s Erdre		France
48	1235.7.3301J Boehringer Ingelheim Investigational Site	La Chapelle sur Erdre		France
49	1235.7.3304A Boehringer Ingelheim Investigational Site	La Fresnais		France
50	1235.7.3308E Boehringer Ingelheim Investigational Site	La Jubaudière		France
51	1235.7.3301G Boehringer Ingelheim Investigational Site	La Montagne		France
52	1235.7.3307D Boehringer Ingelheim Investigational Site	Le Mesnil en Vallée		France
53	1235.7.3301E Boehringer Ingelheim Investigational Site	Le Temple de Bretagne		France
54	1235.7.3309F Boehringer Ingelheim Investigational Site	Les Ponts de CE		France
55	1235.7.3305B Boehringer Ingelheim Investigational Site	Louvigné le Bais		France
56	1235.7.3307E Boehringer Ingelheim Investigational Site	Mouliherne		France
57	1235.7.3306A Boehringer Ingelheim Investigational Site	Murs Erigne		France
58	1235.7.3307A Boehringer Ingelheim Investigational Site	Murs-Erigne		France
59	1235.7.3301A Boehringer Ingelheim Investigational Site	Nantes		France
60	1235.7.3301B Boehringer Ingelheim Investigational Site	Nantes		France
61	1235.7.3301D Boehringer Ingelheim Investigational Site	Nantes		France
62	1235.7.3301M Boehringer Ingelheim Investigational Site	Nantes		France
63	1235.7.3302A Boehringer Ingelheim Investigational Site	Nevers		France
64	1235.7.3302F Boehringer Ingelheim Investigational Site	Nevers		France
65	1235.7.3301I Boehringer Ingelheim Investigational Site	Nort sur Erdre		France
66	1235.7.3301C Boehringer Ingelheim Investigational Site	Orvault		France
67	1235.7.3307F Boehringer Ingelheim Investigational Site	Parcay les Pins		France
68	1235.7.3301N Boehringer Ingelheim Investigational Site	Sautron		France
69	1235.7.3306B Boehringer Ingelheim Investigational Site	Segre		France
70	1235.7.3301F Boehringer Ingelheim Investigational Site	St Aubin les Châteaux		France
71	1235.7.3306F Boehringer Ingelheim Investigational Site	St Georges de Montaigu		France
72	1235.7.3304B Boehringer Ingelheim Investigational Site	St Ouen La Rouerie		France
73	1235.7.3306E Boehringer Ingelheim Investigational Site	Thouars		France
74	1235.7.3304C Boehringer Ingelheim Investigational Site	Tinténiac		France
75	1235.7.3308A Boehringer Ingelheim Investigational Site	Vihiers		France
76	1235.7.82007 Boehringer Ingelheim Investigational Site	Busan		Korea, Republic of
77	1235.7.82001 Boehringer Ingelheim Investigational Site	Daegu		Korea, Republic of
78	1235.7.82006 Boehringer Ingelheim Investigational Site	Daejon		Korea, Republic of
79	1235.7.82004 Boehringer Ingelheim Investigational Site	Gangwon-Do		Korea, Republic of
80	1235.7.82008 Boehringer Ingelheim Investigational Site	Gwangju		Korea, Republic of
81	1235.7.82002 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
82	1235.7.82003 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
83	1235.7.82005 Boehringer Ingelheim Investigational Site	Seoul		Korea, Republic of
84	1235.7.31008 Boehringer Ingelheim Investigational Site	Beerzerveld		Netherlands
85	1235.7.31006 Boehringer Ingelheim Investigational Site	Bennebroek		Netherlands
86	1235.7.31004 Boehringer Ingelheim Investigational Site	Hoogwoud		Netherlands
87	1235.7.31003 Boehringer Ingelheim Investigational Site	Musselkanaal		Netherlands
88	1235.7.31007 Boehringer Ingelheim Investigational Site	Nijverdal		Netherlands
89	1235.7.31001 Boehringer Ingelheim Investigational Site	Oude Pekela		Netherlands
90	1235.7.31005 Boehringer Ingelheim Investigational Site	Roelofarendsveen		Netherlands
91	1235.7.31010 Boehringer Ingelheim Investigational Site	Voerendaal		Netherlands
92	1235.7.47002 Boehringer Ingelheim Investigational Site	Bergen		Norway
93	1235.7.47003 Boehringer Ingelheim Investigational Site	Hamar		Norway
94	1235.7.47004 Boehringer Ingelheim Investigational Site	Oslo		Norway
95	1235.7.47001 Boehringer Ingelheim Investigational Site	Ålesund		Norway
96	1235.7.63006 Boehringer Ingelheim Investigational Site	Makati City		Philippines
97	1235.7.63001 Boehringer Ingelheim Investigational Site	Manila		Philippines
98	1235.7.63002 Boehringer Ingelheim Investigational Site	Manila		Philippines
99	1235.7.63009 Boehringer Ingelheim Investigational Site	Manila		Philippines
100	1235.7.63008 Boehringer Ingelheim Investigational Site	Pasay City		Philippines
101	1235.7.63005 Boehringer Ingelheim Investigational Site	Pasig City		Philippines
102	1235.7.63003 Boehringer Ingelheim Investigational Site	Quezon City		Philippines
103	1235.7.63007 Boehringer Ingelheim Investigational Site	Quezon City		Philippines
104	1235.7.27003 Boehringer Ingelheim Investigational Site	Boksburg		South Africa
105	1235.7.27006 Boehringer Ingelheim Investigational Site	Cape Town		South Africa
106	1235.7.27009 Boehringer Ingelheim Investigational Site	Cape Town		South Africa
107	1235.7.27010 Boehringer Ingelheim Investigational Site	Cape Town		South Africa
108	1235.7.27004 Boehringer Ingelheim Investigational Site	Durban		South Africa
109	1235.7.27007 Boehringer Ingelheim Investigational Site	Johannesburg		South Africa
110	1235.7.27008 Boehringer Ingelheim Investigational Site	Johannesburg		South Africa
111	1235.7.27001 Boehringer Ingelheim Investigational Site	Krugersdorp		South Africa
112	1235.7.27005 Boehringer Ingelheim Investigational Site	Lenasia		South Africa
113	1235.7.27002 Boehringer Ingelheim Investigational Site	Pretoria		South Africa
114	1235.7.46002 Boehringer Ingelheim Investigational Site	Göteborg		Sweden
115	1235.7.46003 Boehringer Ingelheim Investigational Site	Göteborg		Sweden
116	1235.7.46005 Boehringer Ingelheim Investigational Site	Luleå		Sweden
117	1235.7.46004 Boehringer Ingelheim Investigational Site	Rättvik		Sweden
118	1235.7.46001 Boehringer Ingelheim Investigational Site	Stockholm		Sweden
119	1235.7.88605 Boehringer Ingelheim Investigational Site	Changhua		Taiwan
120	1235.7.88608 Boehringer Ingelheim Investigational Site	Hualien City		Taiwan
121	1235.7.88601 Boehringer Ingelheim Investigational Site	Kaohsiung		Taiwan
122	1235.7.88603 Boehringer Ingelheim Investigational Site	Taichung		Taiwan

Sponsors and Collaborators

• Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info
• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00614380
• Other Study ID Numbers: 1235.7; EUDRACT2007-002410-19
• First Posted: Feb 13, 2008
• Last Update Posted: Feb 13, 2014
• Last Verified: Dec 1, 2013

• Additional relevant MeSH terms: Hypertension; Amlodipine; Telmisartan; Telmisartan amlodipine combination

Study Results

Participant Flow

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Period Title: Overall Study
STARTED	564	206	25	181
COMPLETED	529	198	24	179
NOT COMPLETED	35	8	1	2

Baseline Characteristics

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	564	206	25	181	976
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.8 (10.9)	52.9 (10.6)	54.4 (10.8)	52.4 (9.6)	53.9 (10.6)
Sex: Female, Male (Count of Participants)
Female	240 42.6%	72 35%	8 32%	45 24.9%	365 37.4%
Male	324 57.4%	134 65%	17 68%	136 75.1%	611 62.6%

Outcome Measures

1. Primary Outcome

Title	Trough Seated Diastolic Blood Pressure (DBP) Control
Description	The number of patients who reach the target DBP of <90mmHg
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	553	206	25	181
Yes (DBP<90 mmHg)	504 89.4%	160 77.7%	19 76%	84 46.4%
No (DBP>=90 mmHg)	49 8.7%	46 22.3%	6 24%	97 53.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Telmisartan 40mg and Amlodipine 5mg, Telmisartan 80mg and Amlodipine 5mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.34
	Confidence Interval	() 95%; 0.22 to 0.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Telmisartan 40mg and Amlodipine 5mg, Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.31
	Confidence Interval	() 95%; 0.12 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Telmisartan 40mg and Amlodipine 5mg, Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.08
	Confidence Interval	() 95%; 0.06 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Telmisartan 80mg and Amlodipine 5mg, Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.91
	Confidence Interval	() 95%; 0.34 to 2.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Telmisartan 80mg and Amlodipine 5mg, Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.25
	Confidence Interval	() 95%; 0.16 to 0.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive, Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.27
	Confidence Interval	() 95%; 0.10 to 0.72
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Trough Seated Systolic Blood Pressure (SBP) Control
Description	The number of patients who reach the target SBP of <140mmHg
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	553	206	25	181
Yes (SBP<140 mmHg)	440 78%	142 68.9%	16 64%	89 49.2%
No (SBP>=140 mmHg)	113 20%	64 31.1%	9 36%	92 50.8%

3. Secondary Outcome

Title	Change From Baseline in Trough Seated Diastolic Blood Pressure
Description	Change from baseline to the end of study in trough DBP. Baseline is defined as visit 3 of trial 1235.5.
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

All patients who took at least one dose of study medication, have a trough baseline measurement (Visit 3 1235.5) and at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	549	203	24	176
Least Squares Mean (Standard Error) [mmHg]	-14.18 (0.31)	-12.64 (0.52)	-9.47 (1.51)	-10.17 (0.56)

4. Secondary Outcome

Title	Change in DBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
Description	The difference between the last available troughs represents the additional reduction in DBP in this study
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	545	203	24	180
Least Squares Mean (Standard Error) [mmHg]	-3.54 (0.33)	-5.52 (0.55)	-5.51 (1.59)	-5.74 (0.58)

5. Secondary Outcome

Title	Change From Baseline in Trough Seated Systolic Blood Pressure
Description	Change from baseline to the end of study in trough SBP. Baseline is defined as visit 3 of trial 1235.5.
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) included patients who took at least one dose of study medication and have at least one on treatment BP measurement

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	549	203	24	176
Least Squares Mean (Standard Error) [mmHg]	-17.79 (0.52)	-15.91 (0.86)	-12.6 (2.5)	-14.04 (0.92)

6. Secondary Outcome

Title	Change in SBP From Last Available Trough in 1235.5 to Last Available Trough in 1235.7
Description	The difference between the last available troughs represents the additional reduction in SBP in this study
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

All patients who took at least one dose of study medication, have a trough baseline measurement (Last value on treatment in 1235.5) and at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	545	203	24	180
Least Squares Mean (Standard Error) [mmHg]	-4.14 (0.5)	-5.62 (0.83)	-3.6 (2.41)	-7.17 (0.88)

7. Secondary Outcome

Title	Trough Seated DBP Response
Description	The number of patients who reach the target DBP of <90mmHg or had a reduction in DBP >= 10mmHg
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	553	206	25	181
Yes (Responder)	504 89.4%	171 83%	19 76%	108 59.7%
No (Non-responder)	45 8%	32 15.5%	5 20%	68 37.6%

8. Secondary Outcome

Title	Trough Seated SBP Response
Description	The number of patients who reach the target SBP of <140mmHg or had a reduction in SBP >= 15 mmHg
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	553	206	25	181
Yes (Responder)	490 86.9%	179 86.9%	18 72%	128 70.7%
No (Non-responder)	59 10.5%	24 11.7%	6 24%	48 26.5%

9. Secondary Outcome

Title	Trough Blood Pressure (BP) Normality Classes
Description	The number of patients who reach predefined BP categories
Time Frame	End of study (34 weeks or last value on treatment)

Outcome Measure Data

Analysis Population Description

The full analysis set of patients. All patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg	Telmisartan 80mg and Amlodipine 5mg	Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive	Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive
Arm/Group Description
Measure Participants	553	206	25	181
Optimal (SBP<120 and DBP<80 mmHg)	67 11.9%	4 1.9%	1 4%	6 3.3%
Normal (SBP<130 and DBP<85 mmHg and not optimal)	188 33.3%	29 14.1%	3 12%	12 6.6%
High-normal (SBP<140 DBP<90 mmHg and not normal)	163 28.9%	92 44.7%	9 36%	34 18.8%
Stage 1 hypertension (SBP<160 and DBP<100 mmHg	122 21.6%	73 35.4%	12 48%	105 58%
Stage 2 hypertension (SBP>=160 and DBP>=100 mmHg)	13 2.3%	8 3.9%	0 0%	24 13.3%

10. Secondary Outcome

Title	Time to First Additional Antihypertensive
Description	Time from first intake of medication to first intake of an antihypertensive other than the study drug
Time Frame	At any point during open-label treatment

Outcome Measure Data

Analysis Population Description

Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Total
Arm/Group Description
Measure Participants	218
Mean (Standard Deviation) [Days]	85.8 (38.4)

11. Secondary Outcome

Title	Patients Requiring Additional Antihypertensive Therapy to Achieve DBP Control
Description	The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before taking additional antihypertensive compared to last trough DBP taken on treatment
Time Frame	At any point during open-label treatment

Outcome Measure Data

Analysis Population Description

Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Pre-antihypertensive: Yes (DBP<90 mmHg)	Pre-antihypertensive: No (DBP>=90 mmHg)	Pre-antihypertensive: Total
Arm/Group Description
Measure Participants	12	206	218
Post-antihypertensive: Yes (DBP<90 mmHg)	10 1.8%	100 48.5%	110 440%
Post-antihypertensive: No (DBP>=90 mmHg)	2 0.4%	106 51.5%	108 432%
Post-antihypertensive: Total	12 2.1%	206 100%	218 872%

12. Secondary Outcome

Title	Additional Reduction in DBP by Use of Additional Antihypertensive Therapy
Description	Difference in trough DBP from last visit before add-on therapy and last visit during 1235.7
Time Frame	At any point during open-label treatment

Outcome Measure Data

Analysis Population Description

Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Total
Arm/Group Description
Measure Participants	218
Mean (Standard Deviation) [mmHg]	-5.73 (7.65)

13. Secondary Outcome

Title	Additional Reduction in SBP by Use of Additional Antihypertensive Therapy
Description	Difference in trough SBP from last visit before add-on therapy and last visit during 1235.7
Time Frame	At any point during open-label treatment

Outcome Measure Data

Analysis Population Description

Patients from the full analysis set who took additional antihypertensive medication as defined by the investigator. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Total
Arm/Group Description
Measure Participants	218
Mean (Standard Deviation) [mmHg]	-7.53 (11.21)

14. Secondary Outcome

Title	Trough DBP Control Pre- and Post- Uptitration
Description	The number of patients with DBP control (DBP<90 mmHg). Last trough DBP measurement before uptitration to Telmisartan 80mg compared to first trough DBP taken after uptitration
Time Frame	At any point during open-label treatment

Outcome Measure Data

Analysis Population Description

Patients from the full analysis set who up-titrated to the higher dose of telmisartan 80 mg and amlodipine 10 mg. Full analysis set defined as all patients who took at least one dose of study medication and have at least one on treatment BP measurement 20-30 hours post dose

Arm/Group Title	Pre-titration: Yes (DBP<90 mmHg)	Pre-titration: No (DBP>=90 mmHg)	Pre-titration: Total
Arm/Group Description
Measure Participants	17	361	378
Post-titration: Yes (DBP<90 mmHg)	17 3%	190 92.2%	207 828%
Post-titration: No (DBP>=90 mmHg)	0 0%	171 83%	171 684%
Post-titration: Total	17 3%	361 175.2%	378 1512%

Adverse Events

Time Frame	From day of first dose until one day after last dose
Adverse Event Reporting Description	Safety analysis treatment groups were based upon actual treatment received at the time of the event regardless of add-on antihypertensive. All patients started the study on Telmisartan 40mg and amlodipine 5mg and were up-titrated according to DBP response. Explaining the large number of patients exposed to T40/A5 compared to T80/A5
Arm/Group Title	Telmisartan 40mg and Amlodipine 5mg		Telmisartan 80mg and Amlodipine 5mg
Arm/Group Description
All Cause Mortality
	Telmisartan 40mg and Amlodipine 5mg		Telmisartan 80mg and Amlodipine 5mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Telmisartan 40mg and Amlodipine 5mg		Telmisartan 80mg and Amlodipine 5mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/976 (2.3%)		6/397 (1.5%)
Cardiac disorders
Acute myocardial infarction	1/976 (0.1%)		1/397 (0.3%)
Atrial fibrillation	1/976 (0.1%)		0/397 (0%)
Cardiac failure	0/976 (0%)		1/397 (0.3%)
Cronary artery disease	1/976 (0.1%)		0/397 (0%)
Mitral valve incompetence	0/976 (0%)		1/397 (0.3%)
Congenital, familial and genetic disorders
Cystic lymphangioma	1/976 (0.1%)		0/397 (0%)
Gastrointestinal disorders
Epigastric discomfort	1/976 (0.1%)		0/397 (0%)
Small intestinal obstruction	1/976 (0.1%)		0/397 (0%)
Infections and infestations
Anal abscess	0/976 (0%)		1/397 (0.3%)
Post procedural cellulitis	0/976 (0%)		1/397 (0.3%)
Typhoid fever	1/976 (0.1%)		0/397 (0%)
Injury, poisoning and procedural complications
Ankle fracture	1/976 (0.1%)		0/397 (0%)
Incisional hernia	1/976 (0.1%)		0/397 (0%)
Joint sprain	1/976 (0.1%)		0/397 (0%)
Radius fracture	1/976 (0.1%)		0/397 (0%)
Investigations
Prostatic specific antigen increased	1/976 (0.1%)		0/397 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/976 (0.1%)		0/397 (0%)
Muscular disorder	1/976 (0.1%)		0/397 (0%)
Osteoarthritis	1/976 (0.1%)		0/397 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/976 (0.1%)		0/397 (0%)
Thyroid neoplasm	0/976 (0%)		1/397 (0.3%)
Nervous system disorders
Dizziness	1/976 (0.1%)		1/397 (0.3%)
Hypotonia	0/976 (0%)		1/397 (0.3%)
Psychiatric disorders
Depression	1/976 (0.1%)		0/397 (0%)
Renal and urinary disorders
Renal colic	1/976 (0.1%)		0/397 (0%)
Urinary bladder polyp	1/976 (0.1%)		0/397 (0%)
Reproductive system and breast disorders
Ovarian cyst	0/976 (0%)		1/397 (0.3%)
Uterine prolapse	0/976 (0%)		1/397 (0.3%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/976 (0.1%)		0/397 (0%)
Respiratory failure	0/976 (0%)		1/397 (0.3%)
Vascular disorders
Perpheral artery aneurysm	1/976 (0.1%)		0/397 (0%)
Other (Not Including Serious) Adverse Events
	Telmisartan 40mg and Amlodipine 5mg		Telmisartan 80mg and Amlodipine 5mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/976 (5.8%)		45/397 (11.3%)
General disorders
Oedema peripheral	32/976 (3.3%)		21/397 (5.3%)
Musculoskeletal and connective tissue disorders
Back pain	25/976 (2.6%)		24/397 (6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.